Commission Delegated Regulation (EU) 2018/762 of 8 March 2018 establishing common safety methods on safety management system requirements pursuant to Directive (EU) 2016/798 of the European Parliament and of the Council and repealing Commission Regulations (EU) No 1158/2010 and (EU) No 1169/2010 (Text with EEA relevance. )

Article 1

Subject matter and scope

Article 2

Definition

For the purposes of this Regulation, ‘safety certification body’ means the body responsible for issuing a single safety certificate, either the Agency or a national safety authority.

Article 3

Safety management system requirements related to railway undertakings

Railway undertakings shall establish their safety management systems in accordance with the requirements set out in Annex I.

Those safety management system requirements shall apply to the single safety certificates referred to in Article 10 of Directive (EU) 2016/798, for the purposes of the assessment of applications and of supervision.

Article 4

Safety management system requirements related to infrastructure managers

Infrastructure managers shall establish their safety management systems in accordance with the requirements set out in Annex II.

Those safety management system requirements shall apply to the safety authorisations referred to in Article 12 of Directive (EU) 2016/798, for the purposes of the assessment of applications and of supervision.

Article 5

Repeal

Regulations (EU) No 1158/2010 and (EU) No 1169/2010 are repealed with effect from 31 October 2025.

Article 6

Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 16 June 2019 in the Member States that have not notified the Agency and the Commission in accordance with Article 33(2) of Directive (EU) 2016/798.

It shall apply from 16 June 2020 in the Member States that have notified the Agency and the Commission in accordance with Article 33(2) of Directive (EU) 2016/798 that they have extended the period for transposition of that Directive and that have not notified the Agency and the Commission in accordance with Article 33(2a) of Directive (EU) 2016/798 that they have further extended that transposition period.

It shall apply in all Member States from 31 October 2020.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX I

Safety management system requirements related to railway undertakings

1. CONTEXT OF THE ORGANISATION

1.1. The organisation shall:

2. LEADERSHIP

2.1.1. Top management shall demonstrate leadership and commitment to the development, implementation, maintenance and continual improvement of the safety management system by:

2.2.1. A document describing the organisation's safety policy is established by the top management and is:

2.2.2. The safety policy shall:

2.3.1. The responsibilities, accountabilities and authorities of staff having a role that affects safety (including management and other staff involved in safety-related tasks) shall be defined at all levels within the organisation, documented, assigned and communicated to them.

2.3.2. The organisation shall ensure that staff with delegated responsibilities for safety-related tasks shall have the authority, competence and appropriate resources to perform their tasks without being adversely affected by the activities of other business functions.

2.3.3. Delegation of responsibility for safety-related tasks shall be documented and communicated to the relevant staff, accepted and understood.

2.3.4. The organisation shall describe the allocation of roles referred to in paragraph 2.3.1. to business functions within and where relevant, outside the organisation (see 5.3. Contractors, partners and suppliers).

2.4.1. Staff, their representatives and external interested parties, as appropriate and where relevant, shall be consulted in developing, maintaining and improving the safety management system in the relevant parts they are responsible for, including the safety aspects of operational procedures.

2.4.2. The organisation shall facilitate the consultation of staff by providing the methods and means for involving staff, recording staff's opinion and providing feedback on staff's opinion.

3. PLANNING

3.1.1.1. The organisation shall:

3.1.1.2. When assessing risk, an organisation shall take into account the need to determine, provide and sustain a safe working environment which conforms to applicable legislation, in particular Directive 89/391/EEC.

3.1.2.1. The organisation shall identify potential safety risks and appropriate safety measures (see 3.1.1. Risk assessment) before the implementation of a change (see 5.4. Management of change) in accordance with the risk management process set out in the Regulation (EU) No 402/2013 (¹), including consideration of the safety risks from the change process itself.

3.2.1. The organisation shall establish safety objectives for relevant functions at relevant levels to maintain and, where reasonably practicable, improve its safety performance.

3.2.2. The safety objectives shall:

3.2.3. The organisation shall have plan(s) to describe how it will achieve its safety objectives.

3.2.4. The organisation shall describe the strategy and plan(s) used to monitor the achievement of the safety objectives (see 6.1. Monitoring).

4. SUPPORT

4.1.1. The organisation shall provide the resources, including competent staff and effective and useable equipment, needed for the establishment, implementation, maintenance and continual improvement of the safety management system.

4.2.1. The organisation's competence management system shall ensure that staff having a role that affects safety are competent in the safety-related tasks for which they are responsible (see 2.3. Organisational roles, responsibilities, accountabilities and authorities), including at least:

4.2.2. The organisation shall provide a training programme, as referred to in points (c), (d) and (f) of paragraph 4.2.1, for staff performing safety-related tasks which ensures that:

4.2.3. Back to work arrangements shall be in place for staff following accidents/incidents or long absences from work, including providing additional training where such a need is identified.

4.3.1. Top management shall ensure that they and their staff having a role that affects safety are aware of the relevance, importance and consequences of their activities and how they contribute to the correct application and the effectiveness of the safety management system, including the achievement of safety objectives (see 3.2. Safety objectives and planning).

4.4.1. The organisation shall define adequate communication channels to ensure that safety-related information is exchanged among the different levels of the organisation and with external interested parties including contractors, partners and suppliers.

4.4.2. To ensure that safety-related information reaches those making judgements and decisions, the organisation shall manage the identification, receipt, processing, generation and dissemination of safety-related information.

4.4.3. The organisation shall ensure that safety-related information is:

4.5.1.1. There is a description of the safety management system including:

4.5.1.2. The organisation shall ensure that an annual safety report is submitted to the relevant national safety authority (or authorities) in accordance with Article 9(6) of Directive (EU) 2016/798, including:

4.5.2.1. The organisation shall ensure that when creating and updating documented information related to the safety management system adequate formats and media are used.

4.5.3.1. The organisation shall control documented information related to the safety management system, in particular its storage, distribution and the control of changes, to ensure its availability, suitability and protection where appropriate.

4.6.1. The organisation shall demonstrate a systematic approach to integrating human and organisational factors within the safety management system. This approach shall:

5. OPERATION

5.1.1. When planning, developing, implementing and reviewing its operational processes, the organisation shall ensure that during operation:

5.1.2. The organisation shall ensure that its operational arrangements conform to the safety-related requirements of applicable Technical Specifications for Interoperability and relevant national rules and any other relevant requirements (see 1. Context of the organisation).

5.1.3. To control risks where relevant for the safety of operational activities (see 3.1.1. Risk assessment), at least the following shall be taken into account:

5.1.4. To control the allocation of responsibilities where relevant for the safety of operational activities, the organisation shall identify responsibilities for coordinating and managing the safe running of trains and movements of vehicles and define how relevant tasks affecting the safe delivery of all services are allocated to competent staff within the organisation (see 2.3. Organisational roles, responsibilities, accountabilities and authorities) and to other external qualified parties when appropriate (see 5.3. Contractors, partners and suppliers).

5.1.5. To control information and communication where relevant for the safety of operational activities (see 4.4. Information and communication), relevant staff (e.g. train crews) shall be advised of the details of any specified conditions of travel, including relevant changes which may result in a hazard, temporary or permanent operational restrictions (e.g. due to specific type of vehicles or to specific routes) and conditions for exceptional consignments, where applicable.

5.1.6. To control competence where relevant for the safety of operational activities (see 4.2. Competence), the organisation shall ensure, in accordance with applicable legislation (see 1. Context of the organisation), for its staff:

5.2.1. The organisation shall manage the safety risks associated with physical assets throughout their life cycle (see 3.1.1. Risk assessment), from design to disposal, and fulfil the human factors requirements in all phases of the life cycle.

5.2.2. The organisation shall:

5.2.3. The organisation shall ensure that its asset management arrangements, where applicable, conform to all essential requirements as set out in the relevant Technical Specifications for Interoperability and any other relevant requirements (see 1. Context of the organisation).

5.2.4. To control risks where relevant for the supply of maintenance (see 3.1.1. Risk assessment), at least the following shall be taken into account:

5.2.5. To control information and communication where relevant for the safe management of assets (see 4.4. Information and communication), the organisation shall take into account:

5.3.1. The organisation shall identify and control safety risks arising from outsourced activities, including operations or cooperation with contractors, partners and suppliers.

5.3.2. To control the safety risks referred to in paragraph 5.3.1, the organisation shall define the criteria for the selection of the contractors, partners and suppliers and the contract requirements they have to meet, including:

5.3.3. In accordance with the process set out in Article 3 of Regulation (EU) No 1078/2012, the organisation shall monitor:

5.4.1. The organisation shall implement and control changes to the safety management system to maintain or improve the safety performance. This shall include decisions at the different stages of the change management and the subsequent review of safety risks (see 3.1.1. Risk assessment).

5.5.1. The organisation shall identify the emergency situations and associated timely measures to be taken to manage them (see 3.1.1. Risk assessment) and to re-establish normal operating conditions in accordance with Regulation (EU) 2015/995 (⁵).

5.5.2. The organisation shall ensure that, for each identified type of emergency:

5.5.3. The organisation shall identify and document the roles and responsibilities of all parties in accordance with Regulation (EU) 2015/995.

5.5.4. The organisation shall have plans for action, alerts and information in case of emergency including arrangements to:

5.5.5. The organisation shall describe how resources and means for emergency management have been allocated (see 4.1. Resources) and how training requirements have been identified (see 4.2. Competence).

5.5.6. The emergency arrangements are regularly tested in cooperation with other interested parties and updated when appropriate.

5.5.7. The organisation shall ensure that competent staff in charge, with adequate language skills, can be contacted easily and without delay by the infrastructure manager and provide the latter with the right level of information.

5.5.8. The organisation shall have a procedure to contact the entity in charge of maintenance or the railway vehicle keeper in the event of an emergency.

6. PERFORMANCE EVALUATION

6.1.1. The organisation shall perform monitoring in accordance with Regulation (EU) No 1078/2012:

6.1.2. The organisation shall regularly monitor at all levels within the organisation the performance of safety-related tasks and intervene if these tasks are not being properly performed.

6.2.1. The organisation shall conduct internal audits in an independent, impartial and transparent way to collect and analyse information for the purposes of its monitoring activities (see 6.1. Monitoring), including:

6.3.1. Top management shall regularly review the continuing adequacy and effectiveness of the safety management system including at least consideration of:

6.3.2. Based on the outputs of its management review, the top management shall take overall responsibility for the planning and implementation of needed changes to the safety management system.

7. IMPROVEMENT

7.1.1. Accidents and incidents related to the organisation's railway operations shall be:

7.1.2. The organisation shall ensure that:

7.1.3. The organisation shall use information relating to the investigation to review the risk assessment (see 3.1.1. Risk assessment), to learn with the aim of improving safety and, where applicable, to adopt corrective and/or improvement measures (see 5.4. Management of change).

7.2.1. The organisation shall continually improve the adequacy and effectiveness of its safety management system, taking into account the framework set out in Regulation (EU) No 1078/2012 and at least the outputs of the following activities:

7.2.2. The organisation shall provide means to motivating staff and other interested parties to be active in improving safety as part of its organisational learning.

7.2.3. The organisation shall provide a strategy to continually improve its safety culture, relying on the use of expertise and recognised methods to identify behavioural issues affecting the different parts of the safety management system and to put in place measures to address these.

ANNEX II

Safety management system requirements related to infrastructure managers

1. CONTEXT OF THE ORGANISATION

1.1. The organisation shall:

1.2. For the purpose of this Annex the following definitions are applied:

2. LEADERSHIP

2.1.1. Top management shall demonstrate leadership and commitment to the development, implementation, maintenance and continual improvement of the safety management system by:

2.2.1. A document describing the organisation's safety policy is established by the top management and is:

2.2.2. The safety policy shall:

2.3.1. The responsibilities, accountabilities and authorities of staff having a role that affects safety (including management and other staff involved in safety-related tasks) shall be defined at all levels within the organisation, documented, assigned and communicated to them.

2.3.2. The organisation shall ensure that staff with delegated responsibilities for safety-related tasks shall have the authority, competence and appropriate resources to perform their tasks without being adversely affected by the activities of other business functions.

2.3.3. Delegation of responsibility for safety-related tasks shall be documented and communicated to the relevant staff, accepted and understood.

2.3.4. The organisation shall describe the allocation of roles referred to in paragraph 2.3.1. to business functions within and where relevant, outside the organisation (see 5.3. Contractors, partners and suppliers).

2.4.1. Staff, their representatives and external interested parties, as appropriate and where relevant, shall be consulted in developing, maintaining and improving the safety management system in the relevant parts they are responsible for, including the safety aspects of operational procedures.

2.4.2. The organisation shall facilitate the consultation of staff by providing the methods and means for involving staff, recording staff's opinion and providing feedback on staff's opinion.

3. PLANNING

3.1.1.1. The organisation shall:

3.1.1.2. When assessing risk, an organisation shall take into account the need to determine, provide and sustain a safe working environment which conforms to applicable legislation, in particular Directive 89/391/EEC.

3.1.2.1. The organisation shall identify potential safety risks and appropriate safety measures (see 3.1.1. Risk assessment) before the implementation of a change (see 5.4. Management of change) in accordance with the risk management process set out in Regulation (EU) No 402/2013, including consideration of the safety risks from the change process itself.

3.2.1. The organisation shall establish safety objectives for relevant functions at relevant levels to maintain and, where reasonably practicable, improve its safety performance.

3.2.2. The safety objectives shall:

3.2.3. The organisation shall have plan(s) to describe how it will achieve its safety objectives.

3.2.4. The organisation shall describe the strategy and plan(s) used to monitor the achievement of the safety objectives (see 6.1. Monitoring).

4. SUPPORT

4.1.1. The organisation shall provide the resources, including competent staff and effective and useable equipment, needed for the establishment, implementation, maintenance and continual improvement of the safety management system.

4.2.1. The organisation's competence management system shall ensure that staff having a role that affects safety are competent in the safety-related tasks for which they are responsible (see 2.3. Organisational roles, responsibilities, accountabilities and authorities), including at least:

4.2.2. The organisation shall provide a training programme, as referred to in points (c), (d) and (f) of paragraph 4.2.1, for staff performing safety-related tasks which ensures that:

4.2.3. Back to work arrangements shall be in place for staff following accidents/incidents or long absences from work, including providing additional training where such a need is identified.